The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released an introductory guide to help medical device manufacturers understand their obligations under the new EU regulations for medical devices (MDR) and in vitro diagnostic devices (IVDR). With the three- (for MDR) and five-year (IVDR) transition periods now underway, the new regulations will apply across EU member states from 26 May 2020 and 2022, respectively. During the transiti...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Seeks Feedback on Proposed Alignment of Australian and European Medical Device Rules The Therapeutic Goods Administration (TGA) of Australia is proposing to align parts of its medical device regulatory requirements with those in place in Europe. TGA is gathering feedback on plans to reclassify surgical mesh and place new requirements on manufacturers of implants wi...

When the EU’s new Medical Devices Regulation ( MDR ) entered into force last month, it set in motion a three-year countdown to the new rules’ full application in 2020. For companies marketing devices in the EU that wish to continue to do so, there is a lot to do in that relatively short time, so it is critical to begin as soon as possible. Early preparation is key. Following are six things you should be doing to get ready. 1. Plan Ahead In order to figure out wh...

The European Medicines Agency (EMA) on Tuesday opened for public consultation a draft guideline on serious breaches of clinical trial regulations or clinical trial protocols. The agency says the guideline is intended to "outline the practical arrangements for notification of serious breaches … provide advice on what should and what should not be classified as a serious breach and what must be reported … [and] To outline possible actions that may be taken by the EU/...

RAPS is bringing together a panel of Europe’s top industry experts to deliver a dedicated workshop on the new EU regulations for medical devices and in vitro diagnostic devices. ‘ EU Regulatory Essentials, Medical Device and In Vitro Diagnostics: Transitioning from Current Directives to New Regulations ’ will take place on 4 and 5 July in Brussels and will introduce and explain the new EU regulations. Offered for the first time in Europe, the workshop will also...

A petition submitted to the US Food and Drug Administration (FDA) in 2016 has been updated recently, as it seeks to reform FDA requirements for investigational new drug (IND) applications, investigational device exemptions (IDEs) and new drug applications (NDAs). In a letter submitted in April, the Center for Responsible Science noted 19 treatment-related deaths in clinical trials from July 2016 through April 2017. Among those were five clinical trial participants w...

The final texts of the new European medical device and in vitro diagnostic (IVD) regulations were published on Friday in the Official Journal of the European Union , setting in motion the timeline for implementation of the new regulations to commence on 25 May. Gert Bos, executive director at Qserve Group and a RAPS board member, explained to attendees of the MedCon conference in Cincinnati on Thursday some of the difficulties that industries will face over the ...

The Association of Accessible Medicines (AAM), formerly known as the Generic Pharmaceutical Association, has recommended five major US Food and Drug Administration (FDA) regulation tweaks in a letter to the Department of Commerce. In addition to citing a lack of clarity in the regulations governing the permitting processes of large life sciences projects, David Gaugh, SVP for sciences and regulatory affairs at AAM, called for five actions to reduce the regulatory bu...

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday released a business plan for the upcoming year, noting its primary focus on developing a consensus around a proposed model for the future of the country’s regulation of medicines and medical devices following its departure from the EU. MHRA is pushing for a more international strategy that focuses on collaboration and engagement with key partners and stakeholders and continuing to partici...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Forms Leadership Group to Reform Drug Pricing Legislation, NPPA India has convened a committee to consider reforms to drug pricing legislation and the agency that enforces the rules. Officials at the Department of Pharmaceuticals took the step in response to feedback from regulators and industry about the shortcomings of the existing pricing legislation and mech...

More than a dozen House and Senate Democrats late Wednesday unveiled a host of new provisions to bring down the rising cost of pharmaceuticals, offering up many ideas that have been publicly opposed by the pharmaceutical industry. The bill, known as the Improving Access to Affordable Prescription Drugs Act , was introduced alongside a House companion , though neither is likely to gain much traction in the Republican-controlled House and Senate. However, some of the b...

Beginning on Tuesday, 14 March, amendments to Canada’s Food and Drug Regulations will come into force making it mandatory for drug authorization holders to publicly report drug shortages and discontinuations to two websites, DrugShortagesCanada.ca and PenuriesDeMedicamentsCanada.ca. “As soon as a market authorization holder knows that it will take longer than 20 days to supply a drug to meet expected patient volumes on an ongoing basis, they will report this as a...